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Change in Inhaler Use, Lung Function, and Oxygenation in Association with Symptoms in COPD.

ABSTRACT: Despite clinical guidelines for chronic obstructive pulmonary disease (COPD) patients to self-treat worsening respiratory symptoms with supplemental inhaler/nebulizer use, few studies have investigated if symptom changes are associated with differences in oxygenation, lung function, or self-treatment. A total of 26 former smokers (mean age 72.7 ±7.5 years; 57.7% female) with COPD (? Global Initiative for Chronic Obstructive Lung Disease Stage 2) were followed for up to 4 months, during which they recorded daily oxygenation, lung function, and inhaler/nebulizer use. Differences in these health measures were assessed in association with self-reported worsening symptoms and COPD exacerbations, as defined by validated questionnaire. We collected 2451 observations with spirometry and questionnaire data and identified 253 symptom days (10.3%) and 47 (1.92%) exacerbation days. In linear mixed effects models adjusted for age, sex, race, height, weight, and season, each respiratory symptom reported worse than baseline was associated with a 0.19 percentage point (95% CI -0.31 to -0.07) lower daily oxygen saturation (p=0.002). On major symptom days (defined as worse-than-baseline dyspnea, sputum purulence or sputum amount), oxygen saturation was 0.56 percentage points lower (95% CI -0.89 to -0.23, p=0.001) than days without increased major symptoms. We found no association of symptom days or exacerbations with forced expiratory volume in 1 second. There were 8 reports of increased inhaler/nebulizer use from baseline on symptom days (1.5% of 253). In this moderate-to-severe COPD population, worsening respiratory symptoms were common and associated with lower oxygenation. However, participants did not self-treat symptoms with increased inhaler/nebulizer use, which may suggest poor perceived clinical benefit from short-acting bronchodilators and a potential target for patient education.

SUBMITTER: Sun WY

PROVIDER: S-EPMC7883906 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Change in Inhaler Use, Lung Function, and Oxygenation in Association with Symptoms in COPD.

Sun Wendy Y WY Zhang Chunyi C Synn Andrew J AJ Nurhussien Lina L Coull Brent A BA Rice Mary B MB

Chronic obstructive pulmonary diseases (Miami, Fla.) 20201001 4

Despite clinical guidelines for chronic obstructive pulmonary disease (COPD) patients to self-treat worsening respiratory symptoms with supplemental inhaler/nebulizer use, few studies have investigated if symptom changes are associated with differences in oxygenation, lung function, or self-treatment. A total of 26 former smokers (mean age 72.7 ±7.5 years; 57.7% female) with COPD (≥ Global Initiative for Chronic Obstructive Lung Disease Stage 2) were followed for up to 4 months, during which the ...[more]

PMID: 33108109

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Project description:BackgroundCurrently, in Japan, shifting tasks from physician to hospital pharmacist is being developed to reduce physician workload and improve the quality of pharmacotherapy. This study aimed to investigate the effects of pharmacist involvement in the choice of inhaler as the task on the clinical outcomes of patients with chronic obstructive pulmonary disease (COPD).MethodsThis prospective, single-center, single-arm study included 36 outpatients with newly diagnosed COPD indicating inhaler therapy. Eligible patients were immediately interviewed by pharmacist. Then, pharmacist assessed patient's inhalation flow rate, physical function to handle an inhaler, comprehension, and value, and finally recommended a personalized inhaler based on originally developed inhaler choice protocol, and pulmonologist prescribed a pharmacist-selected inhaler. The primary endpoint was the improvement in trough forced expiratory volume in 1 s (FEV1) between baseline and week 26. The secondary endpoints were safety, and improvements at week 26 in scores for the COPD Assessment Test (CAT), modified British Medical Research Council Dyspnea Scale (mMRC), and Adherence Starts with Knowledge-20 (ASK-20).ResultsThe pneumonologists completely agreed with the pharmacist-recommended inhaler. Mean FEV1 significantly increased from baseline to week 26 (1.60, SD 0.54 L vs. 1.98, SD 0.56 L; p < 0.0001). Significant improvements in CAT, mMRC, and ASK-20 scores were also observed. The prevalence of CAT responders as a negative predictor of acute exacerbation, defined as those with a decrease in CAT score of ≥2 points from baseline, was 86%. None of the patients experienced exacerbation during the study period.ConclusionsPharmacist involvement in the choice of inhaler for patients with newly diagnosed COPD was associated with improved lung function, health status, clinical symptoms, and adherence to inhaler therapy. Shifting task of choosing appropriate inhaler from physician to hospital pharmacist may be performed effectively and safely with an inhaler choice protocol.Trial registration numberUMIN000039722 , retrospectively registered on March 10, 2020.

Project description:BACKGROUND:The comparative efficacy of inhaled corticosteroid/long-acting muscarinic antagonist/long-acting ?2-agonist (ICS/LAMA/LABA) triple therapy administered via single or multiple inhalers in patients with chronic obstructive pulmonary disease (COPD) has not been evaluated comprehensively. We conducted two replicate trials comparing single- with multiple-inhaler ICS/LAMA/LABA combination in COPD. METHODS:207608 and 207609 were Phase IV, 12-week, randomized, double-blind, triple-dummy non-inferiority trials comparing once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25??g via Ellipta inhaler, with twice-daily budesonide/formoterol (BUD/FOR) 400/12??g via metered-dose inhaler plus once-daily tiotropium (TIO) 18??g via HandiHaler. Patients had symptomatic COPD and forced expiratory volume in 1?s (FEV1) <?50% predicted, or FEV1 <?80% predicted and???2 moderate or 1?severe exacerbations in the prior year. The primary endpoint in both trials was weighted mean change from baseline (wmCFB) in 0-24-h FEV1 at Week 12. Secondary endpoints included CFB in trough FEV1 at Day 84 and 85. Other endpoints included serial FEV1 and health status outcomes at Week 12. Safety was evaluated descriptively. RESULTS:The modified per-protocol population included 720 and 711 patients in studies 207608 and 207609 (intent-to-treat population: 728 and 732). FF/UMEC/VI was non-inferior to BUD/FOR+TIO for wmCFB in 0-24-h FEV1 at Week 12 (Study 207608 treatment difference [95% confidence interval]: 15?mL [-?13, 43]; Study 207609: 11?mL [-?20, 41]). FF/UMEC/VI improved trough FEV1 CFB versus BUD/FOR+TIO at Day 84 and 85 (Day 85 treatment difference: Study 207608: 38?mL [10, 66]; Study 207609: 51?mL [21, 82]) and FEV1 at 12 and 24?h post-morning dose at Week 12 in both studies. No treatment differences were seen in health status outcomes. Safety profiles were similar between treatments; pneumonia occurred in 7 (<?1%) patients with FF/UMEC/VI and 9 (1%) patients with BUD/FOR+TIO, across both studies. CONCLUSIONS:FF/UMEC/VI was non-inferior to BUD/FOR+TIO for wmCFB in 0-24-h FEV1 at Week 12 in patients with COPD. Greater improvements in trough and serial FEV1 measurements at Week 12 with FF/UMEC/VI versus BUD/FOR+TIO, together with similar health status improvements and safety outcomes including the incidence of pneumonia, suggest that once-daily single-inhaler FF/UMEC/VI triple therapy is a viable option for patients looking to simplify their treatment regimen. TRIAL REGISTRATION:GSK (207608/207609; NCT03478683/NCT03478696).

Project description:RationalePlasma soluble Receptor for Advanced Glycation End Product (sRAGE) is considered as a biomarker in COPD. The contribution of endogenous sRAGE (esRAGE) to the pool of plasma sRAGE and the implication of both markers in COPD pathogenesis is however not clear yet. The aim of the current study was therefore to measure plasma levels of esRAGE comparative to total sRAGE in patients with COPD and a control group. Further, we established the relations of esRAGE and total sRAGE with disease specific characteristics such as lung function and DLCO, and with different circulating AGEs.MethodsPlasma levels of esRAGE and sRAGE were measured in an 88 patients with COPD and in 55 healthy controls. FEV1 (%predicted) and FEV1/VC (%) were measured in both groups; DLCO (%predicted) was measured in patients only. In this study population we previously reported that the AGE N?-(carboxymethyl) lysine (CML) was decreased, N?-(carboxyethyl) lysine (CEL) increased and pentosidine was not different in plasma of COPD patients compared to controls.ResultsPlasma esRAGE (COPD: 533.9 ± 412.4, CONTROLS: 848.7 ± 690.3 pg/ml; p = 0.000) was decreased in COPD compared to controls. No significant correlations were observed between plasma esRAGE levels and lung function parameters or plasma AGEs. A positive correlation was present between esRAGE and total sRAGE levels in the circulation. Confirming previous findings, total sRAGE (COPD: 512.6 ± 403.8, CONTROLS: 1834 ± 804.2 pg/ml; p < 0.001) was lower in patients compared to controls and was positively correlated FEV1 (r = 0.235, p = 0.032), FEV1/VC (r = 0.218, p = 0.047), and DLCO (r = 0.308, p = 0.006). sRAGE furthermore did show a significant positive association with CML (r = 0.321, p = 0.003).ConclusionAlthough plasma esRAGE is decreased in COPD patients compared to controls, only total sRAGE showed a significant and independent association with FEV1, FEV1/VC and DLCO, indicating that total sRAGE but not esRAGE may serve as marker of COPD disease state and severity.

Dataset Information

Change in Inhaler Use, Lung Function, and Oxygenation in Association with Symptoms in COPD.

Publications

Change in Inhaler Use, Lung Function, and Oxygenation in Association with Symptoms in COPD.

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